Finding Early Predictors of Myocardial Dysfunction
Finding Early Predictors of Myocardial Dysfunction in Patients With Hypertension - Pilot Study.
調査の概要
詳細な説明
The study is to allow for identification of patients with hypertension, in whom an early introduction of pharmacological treatment of heart failure HF should be considered. Evaluation in the detection of asymptomatic myocardial dysfunction will include potential heart failure markers such as: cardiotrophin 1, cystatin C, serum syndecan-4, collagen III N-terminal propeptide [PIIINP], NT-proBNP, IL1RL1 and modern echocardiography methods in order to increase the effectiveness of prevention, diagnosis and treatment optimalization.
Material and study plan about 100 persons (age 30-70 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension: Group A- 15 patients without symptoms of heart failure Group B- 30 patients with exertional dyspnoea Group C - 40 patients with overt heart failure
In group B (patients with exertional dyspnea/stenocardia) we will include only patients who have undergone CT coronary angiography without any identified changes in the epicardial coronary arteries, which will facilitate answering the presented purpose of research. Patients in groups A and B with normal resting echocardiography and treated with a maximum of 2 antihypertensive drugs (an ACE inhibitor or a sartan as therapy base), according to the following regimen:
ACEI/ARB + diuretic ACEI/ARB + calcium channel antagonist Group C - treatment in accordance with the standards for heart failure. Each patient will be informed about the objectives of the study and give written consent to participate.
After signing informed consent patients will have performed the following tests:
- Interview and documentation analysis,
- Physical examination,
- Electrocardiogram
- Echocardiography at rest and during submaximal exercise on a bicycle ergometer
- Levels of markers: cystatin C, cardiotrophin-1, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP, IL1RL1. Each patient will be informed about the objectives of the study and give written consent to participate.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Lodz、ポーランド
- Department of Hypertension, Medical University of Lodz
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- persons (age 30-70 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension
Exclusion Criteria:
- with coronary artery disease or a history of coronary artery disease (A, B)
- with unstable hypertension
- with a positive stress test
- with NYHA class III-IV heart failure
- after percutaneous or surgical revascularization
- with diabetes
- with GFR < 60
- with hyperthyroidism and hypothyroidism
- active smokers
- with an implanted pacemaker
- with obesity level II and III
- with ECG-arrhythmia
- pregnant and lactating
- with congenital heart disease
- with hemodynamically significant acquired heart defects
- with cardiomyopathies (A,B)
- with cancer
- with anemia
- abusing alcohol or drugs
- with chronic inflammatory and other diseases
- or who have not given their informed consent to participate in the study
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
---|
A, B, C
Group A- 15 patients without symptoms of heart failure - control group Group B- 30 patients with exertional dyspnoea Group C - 40 patients with overt heart failure
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of patients with changes in echocardiography during exercise
時間枠:1 year
|
Echocardiography at rest and during submaxinal exercise on a bicycle ergometer
|
1 year
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Changes in biomarkers levels according to clinical symptoms and echocardiography results
時間枠:1 year
|
1 year
|
協力者と研究者
捜査官
- 主任研究者:Agata Bielecka-Dabrowa, PhD、Medical University of Lodz
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)